BioCentury on BioBusiness,
How FDA raised bar on Novo Nordisk's insulin degludec products
No-go for Novo
Monday, February 18, 2013
FDA's dogged effort to uncover any potential cardiovascular
risk associated with Novo
Nordisk A/S's insulin degludec products effectively raised the bar for
approval twice, leaving the company and patients facing a prolonged delay in
FDA first waved off a CV risk
analysis of Tresiba insulin degludec and Ryzodeg insulin degludec/insulin
aspart that had been agreed with the company.
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